In the last six months, there have been tragedies in Karnataka and West Bengal due to contaminated ringer lactase solution manufactured by the same pharmaceutical company in Bengal. In total, six young mothers died, with several others hospitalised with critical illnesses. In both states, the Opposition parties heaped criticism on the health ministers. Deaths due to contaminated drugs have been political dynamite especially when they occur in government hospitals. Yet, states are doing precious little to reform the bureaucracies responsible for drug quality.
To be fair, state health ministers are caught between a rock and a hard place because of the fragmented regulatory framework under the Drugs & Cosmetics Act, 1940 which allows only the Union government to set quality standards and leaves enforcement of these standards to individual states. As a result, India has 37 drug regulators – one for each state and Union Territory in addition to a national regulator. These 37 regulators are inept at coordinating or sharing information with each other. These issues combined with jurisdictional issues render these regulators incapable of dealing with a nimble footed pharmaceutical industry which knows how to slip through the regulatory cracks. Therefore, when drugs fail testing in one state and are declared to be Not of Standard Quality (NSQ), there is no system in place to instantly share the test reports with all state drug controllers across the country, along with details such as batch numbers and sales records, which are crucial to trace the NSQ batch. Thus, even after Karnataka linked the deaths of the five young mothers in November to the contaminated ringer lactase, West Bengal did not do enough to ensure that the same drugs were recalled from its own hospitals and pharmacies.
One could argue that the buck stops with the Union health ministry which has repeatedly failed to put in place a mandatory recall system for drugs declared NSQ. After all, the Union health ministry has known about this problem since 1976; it has been discussed several times at meetings of the Drugs Consultative Committee and Drugs Technical Advisory Board with no concrete action, despite a consensus on the need for a national recall system.
{{/usCountry}}One could argue that the buck stops with the Union health ministry which has repeatedly failed to put in place a mandatory recall system for drugs declared NSQ. After all, the Union health ministry has known about this problem since 1976; it has been discussed several times at meetings of the Drugs Consultative Committee and Drugs Technical Advisory Board with no concrete action, despite a consensus on the need for a national recall system.
{{/usCountry}}Some states have decided to act on their own. For example, West Bengal on March 6 issued an order to require a limited state recall of all drugs that are declared NSQ. This order requires both the public and private sector to stop the sale of NSQ drugs when informed of the same, but since it does not have the force of the law, it can at most can be considered a plea not a command.
In any event, even if the order was backed by the force of the law, it would fail because it is poorly designed. To begin with, it places the responsibility of withdrawal of NSQ drugs entirely on private pharmacies and distributors and makes a vague threat of random inspections and legal actions against those licensees who fail to stop the sale of these NSQ drugs. But the fact of the matter is that pharmacies and wholesalers faced with the prospect of financial losses will simply continue selling NSQ drugs. Section 19 of the Drugs & Cosmetics Act offers them qualified immunity from prosecution.
Even if the drug inspectors were to circumvent this immunity, the fact remains that the offence of selling NSQ drugs in India has been converted into a compoundable offence by the Jan Vishwas Act enacted by Parliament in 2023. This means that pharmacies and distributors can escape prosecution for a first offence by paying a pitiful fine of Rs 20,000. Given the complete lack of deterrence under the law, profit-seeking pharmacies and distributors in the private sector will continue selling NSQ drugs.
Given this reality, states must impose the duty of recall on their own drug inspectors, at least for the most dangerous NSQ drugs, like contaminated injectables or parentals used in acute care. The Drugs & Cosmetics Act, 1940 gives the state drug inspectors the power to call for sales records (S. 18A & S.18B) of the NSQ batch and seize the NSQ drugs [S. 22(c)] so that they cannot be sold pending the conclusion of legal proceedings.
In our experience, drug control departments in state governments are loathe to take upon themselves the responsibility of conducting a recall, despite it being in their job description. But health ministers in state governments need to understand that the drug inspectors, not pharmacies or distributors, are accountable to them. Given the political risk faced by the states due to NSQ drugs, their safest bet is to impose the duty of recalls on drug inspectors who are under the state government.
Apart from physically removing NSQ drugs from the market, the states should also require their highest-ranking bureaucrats in the health department to reveal to the media the details of the recall, along with batch numbers and steps being taken to pull the NSQ drug off the market. This should be accompanied by advertisements in local newspapers. The aim of this exercise should be to make doctors and the public aware of NSQ drugs circulating in the market.
All these are stopgap measures and are unlikely to prevent future tragedies because many states simply do not conduct enough testing of drugs or share data with the national drug regulator. Given this reality, state health ministers need to demand that the Union health ministry put in place rules which force higher standards of transparency and information sharing between states.
Additionally, state health ministers should also consider instituting better market surveillance measures. Currently, drug inspectors randomly purchase drugs from the market per their budget for testing. Some states like Tamil Nadu tested 57,567 samples in a span of six years, while West Bengal tested just 2,637 samples in the same period. A well-designed sampling strategy, with adequate budgetary support focusing on high-risk drugs like injectables, which are known to have contamination issues in India or antibiotics used in critical care, may help states gather better data for recalls. Seizures of NSQ drugs by the states, followed by vigorous prosecutions will send a message to the bad players that they are not welcome in our market.
The writers co-authored The Truth Pill: The Myth of Drug Regulation in India. The views expressed are personal